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Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer (PTCA199-3)

Primary Purpose

Metastatic Pancreatic Adenocarcinoma

Status
Recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Ascorbate
Nab paclitaxel
Gemcitabine
Sponsored by
Fudan University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Adenocarcinoma focused on measuring ascorbate, anemia, quality of life, chemotherapy

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document. Age ≥ 18 years and ≤ 80 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Histologically or cytologically confirmed metastatic pancreas adenocarcinoma. Adequate organ performance based on laboratory blood tests. Presence of at least of one measurable lesion in agreement to Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Hemoglobin (Hgb) ≥ 8 g/dL. The expected survival ≥ 3 months. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: Patients who have received any form of anti-tumor therapy. The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas. Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc. Pregnant or nursing women. Glucose-6-phosphate dehydrogenase (G6PD) deficiency. Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines, uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, congestive heart failure (CHF), myocardial infarction in the past 6 months , unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc). Renal insufficiency or dialysis History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, or other agents used in the study. Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment. Patients who are unwilling or unable to comply with study procedures.

Sites / Locations

  • Shanghai Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Ascorbate

Control

Arm Description

nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Vitamin C 900 mg/day, three times a day, orally.

nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.

Outcomes

Primary Outcome Measures

Rate of anemia
Rate of anemia after every cycle of chemotherapy

Secondary Outcome Measures

Rate of hand-foot skin reaction (HFSR)
Rate of HFSR after every cycle of chemotherapy
Change of numeric rating scale (NRS)
Change of NRS and the administration of analgesic drugs after every cycle of chemotherapy. The range of NRS scale is 0-10 and higher scores mean a worse outcome.
Quality of life (QOL)
Change of QOL after every cycle of chemotherapy assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Overall survival (OS)
OS of subjects from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.

Full Information

First Posted
August 17, 2023
Last Updated
August 29, 2023
Sponsor
Fudan University
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1. Study Identification

Unique Protocol Identification Number
NCT06018883
Brief Title
Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer
Acronym
PTCA199-3
Official Title
Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 20, 2023 (Actual)
Primary Completion Date
August 15, 2025 (Anticipated)
Study Completion Date
August 15, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fudan University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
The purpose of this study is to evaluate the efficacy of low-dose vitamin C on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy.
Detailed Description
Pancreatic cancer is a highly lethal malignancy with a 5-year survival less than 10%. Approximately 80% of patients with pancreatic cancer are diagnosed at an advanced stage. Chemotherapy is one of the major treatments for advanced pancreatic cancer. The Metastatic PAncreatic Cancer Trial (MPACT) has confirmed the efficacy of gemcitabine combined with nab-paclitaxel as the first-line treatment to metastatic pancreatic cancer. However, the side-effects related to gemcitabine combined with nab-paclitaxel including anemia, hand/foot numbness, fatigue, nausea, and malnutrition have impaired the tolerability of the regimen. Vitamin C, also called ascorbate, is an essential nutrient for the human body. It modulates metabolism, immune reaction, collagen synthesis, and iron absorption. Some studies have shown that high-dose intravenous Vitamin C may be effective against various types of cancer. Meanwhile, medium or low dose of Vitamin C may enhance the tolerability of chemotherapy by increasing iron absorption, improving anemia, alleviating pain and hand/foot numbness, and thus improving quality of life for patients with pancreatic cancer. The purpose of this study is to evaluate the efficacy of low-dose vitamin C on improving the quality of life for metastatic pancreatic cancer patients receiving gemcitabine and nab-paclitaxel chemotherapy. One hundred patients will be randomly assigned to the experimental group (gemcitabine combined with nab-paclitaxel, Vitamin C) or the control group (gemcitabine combined with nab-paclitaxel). Rate of anemia, rate of hand/foot numbness, severity of pain, quality of life, and overall survival are measured every four weeks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Adenocarcinoma
Keywords
ascorbate, anemia, quality of life, chemotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ascorbate
Arm Type
Experimental
Arm Description
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks. Vitamin C 900 mg/day, three times a day, orally.
Arm Title
Control
Arm Type
Other
Arm Description
nab-paclitaxel (120 mg per square meter of body-surface area) followed by gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks.
Intervention Type
Drug
Intervention Name(s)
Ascorbate
Other Intervention Name(s)
Vitamin C
Intervention Description
Vitamin C 900 mg/day, three times a day, orally.
Intervention Type
Drug
Intervention Name(s)
Nab paclitaxel
Other Intervention Name(s)
Nab-paclitaxel
Intervention Description
Nab-paclitaxel (120 mg per square meter of body-surface area) on days 1, 8, and 15 every 4 weeks
Intervention Type
Drug
Intervention Name(s)
Gemcitabine
Other Intervention Name(s)
Gemcitabine Hydrochloride
Intervention Description
Gemcitabine (1000 mg per square meter) on days 1, 8, and 15 every 4 weeks
Primary Outcome Measure Information:
Title
Rate of anemia
Description
Rate of anemia after every cycle of chemotherapy
Time Frame
At the end of Cycle 1 (each cycle is 28 days)
Secondary Outcome Measure Information:
Title
Rate of hand-foot skin reaction (HFSR)
Description
Rate of HFSR after every cycle of chemotherapy
Time Frame
At the end of Cycle 1 (each cycle is 28 days)
Title
Change of numeric rating scale (NRS)
Description
Change of NRS and the administration of analgesic drugs after every cycle of chemotherapy. The range of NRS scale is 0-10 and higher scores mean a worse outcome.
Time Frame
At the end of Cycle 1 (each cycle is 28 days)
Title
Quality of life (QOL)
Description
Change of QOL after every cycle of chemotherapy assessed using European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)
Time Frame
At the end of Cycle 1 (each cycle is 28 days)
Title
Overall survival (OS)
Description
OS of subjects from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months.
Time Frame
At the end of Cycle 1 (each cycle is 28 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Ability to understand and the willingness to sign a written informed consent document. Age ≥ 18 years and ≤ 80 years. Eastern Cooperative Oncology Group (ECOG) performance status 0-2. Histologically or cytologically confirmed metastatic pancreas adenocarcinoma. Adequate organ performance based on laboratory blood tests. Presence of at least of one measurable lesion in agreement to Response Evaluation Criteria in Solid Tumours (RECIST) criteria. Hemoglobin (Hgb) ≥ 8 g/dL. The expected survival ≥ 3 months. Women of childbearing potential and men must agree to use adequate contraception prior to study entry and for the duration of study participation. Exclusion Criteria: Patients who have received any form of anti-tumor therapy. The diagnosis was confirmed by pathology as non-adenocarcinoma of pancreas. Inflammation of the digestive tract, including pancreatitis, cholecystitis, cholangitis, etc. Pregnant or nursing women. Glucose-6-phosphate dehydrogenase (G6PD) deficiency. Severe and uncontrollable accompanying diseases that may affect protocol compliance or interfere with the interpretation of results, including active opportunistic infections or advanced (severe) infections, and diabetes that cannot be controlled after adequate clinical anti-hyperglycemia treatment according to guidelines, uncontrollable hypertension, cardiovascular disease (Class III or IV heart failure as defined by the New York Heart Association classification, congestive heart failure (CHF), myocardial infarction in the past 6 months , unstable arrhythmia or unstable angina, cerebral infarction within 3 months, etc). Renal insufficiency or dialysis History of allergic reactions attributed to compounds of similar chemical or biologic composition to gemcitabine, nab-paclitaxel, or other agents used in the study. Other serious accompanying illnesses, which, in the researcher's opinion, could seriously adversely affect the safety of the treatment. Patients who are unwilling or unable to comply with study procedures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ying Yang, MD
Phone
86 21 64175590
Ext
1307
Email
yangying@fudanpci.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guopei Luo, MD
Organizational Affiliation
Fudan University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai Cancer Center
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200032
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ying Yang, MD
Phone
86 21 64175590
Ext
1307
Email
yangying@fudanpci.org

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32102933
Citation
Magri A, Germano G, Lorenzato A, Lamba S, Chila R, Montone M, Amodio V, Ceruti T, Sassi F, Arena S, Abrignani S, D'Incalci M, Zucchetti M, Di Nicolantonio F, Bardelli A. High-dose vitamin C enhances cancer immunotherapy. Sci Transl Med. 2020 Feb 26;12(532):eaay8707. doi: 10.1126/scitranslmed.aay8707.
Results Reference
result
PubMed Identifier
29438178
Citation
Drisko JA, Serrano OK, Spruce LR, Chen Q, Levine M. Treatment of pancreatic cancer with intravenous vitamin C: a case report. Anticancer Drugs. 2018 Apr;29(4):373-379. doi: 10.1097/CAD.0000000000000603.
Results Reference
result
PubMed Identifier
26201606
Citation
Cieslak JA, Cullen JJ. Treatment of Pancreatic Cancer with Pharmacological Ascorbate. Curr Pharm Biotechnol. 2015;16(9):759-70. doi: 10.2174/138920101609150715135921.
Results Reference
result

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Vitamin C to Chemotherapy Related Anemia in Pancreatic Cancer

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